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The Surgical lights CHROMOPHARE® D500, D630 and D650, are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.

The Berchtold CHROMOPHARE® D Series lights are suitable for all types of surgical procedures and offers the physician a natural (whiter) and "colder" light. The light intensity from 85000lx up to 150000 lux. The light incorporates easy-to-operate switching on the second lamp in case of failure of the main lamp and an easy to exchange lamp cartridge. For the CHROMOPHARE® D650 and D530 is also an optional CCD-video camera available and a special version with "EndoLite" for endoscopical work. The light could be combined with other Berchtold lights and the Hermes OR Control Center from Voice - Sense - See in the EC and Hermes Motion, Inc. The light has been designed to and meets the requirements of the IEC 601 and UL 544 regulation for safety.

The provided text describes a 510(k) summary for surgical lights (CHROMOPHARE® D500, D530, D650). It details the device, its intended use, and claims substantial equivalence to a previously cleared device. However, it does not contain any information regarding acceptance criteria or a study proving device performance against such criteria for AI/ML-driven medical devices.

The document pre-dates widespread use of AI/ML in medical devices and focuses on the physical and functional aspects of surgical lighting, referencing compliance with safety regulations like IEC 601 and UL 544.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval for basic medical equipment, not sophisticated analytical devices requiring performance studies with ground truth and expert adjudication.

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